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ID NOW Strep A 2 Control Swab Kit

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
ID NOW Strep A 2 Control Swab Kit FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI
Device Name
Control Swabs intended for use only with the ID NOW Strep A 2 product. FDA UDI
Model / Reference
734-080 FDA UDI
Description
Control Swabs intended for use only with the ID NOW Strep A 2 product. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010583 FDA UDI
FDA Product Code
PGX FDA UDI
OOI FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.2680 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

ID NOW Strep A 2 Control Swab Kit by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 0ace0959-5893-433e-ac77-2434f68c2001 33 fields · synced Jun 8, 2026